Vimala Massage Infantile Colic, Sleep and Development Levels

NCT ID: NCT06993701

Last Updated: 2025-05-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2026-01-01

Brief Summary

Objective: The effect of Vimala massage applied by parents on infantile colic, sleep and developmental levels of infants will be investigated.

Method: The data of the randomised controlled study is planned to be conducted in 3 Family Health Centres in Kilis province between 01 Jun 2025-01 January 2026. The population of the study will consist of infants diagnosed with IC who come to the FHC centre for diagnosis, treatment or follow-up between the specified dates and meet the inclusion criteria.

Detailed Description

The sample size was calculated using the G*Power 3.1.9.7 software, and the required sample size was determined to be 66. To account for potential data loss, the sample size was increased by 10% for each group. As a result, 24 infants were planned for each group (mother massage group, father massage group, and control group), totaling 72 participants. Data will be collected using the Introductory Information Form, Infant Follow-up Form, Infant Colic Scale, Expanded Short Infant Sleep Questionnaire, Parent-Infant Caregiving Touch Scale, and the Massage Practice Competence Evaluation Form.

All data will be collected face-to-face by the researcher, who holds an instructor certificate from the International Association of Infant Massage (IAIM). After the pre-test data are collected, participants will be assigned to the relevant groups. No intervention will be applied to the infants in the control group.

Parents in the mother massage group and father massage group will attend Vimala Massage training sessions once a week for five weeks at pre-scheduled times at Family Health Centers (FHCs). At the end of the fifth week, parents in all groups (mother, father, and control) will be asked to complete the post-test data collection forms.

This study is supported by Atatürk University (Project No: TDK-2025-15472).

Conditions

Massage Effect

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

mother massage group

In family health centers, the time and hour of the massage training will be determined with the mothers of infants diagnosed with IC. At this stage, the researcher will provide face-to-face, applied, one-to-one training on massage to the mothers of the babies in the mother group according to the constructivist learning model. Each training will be explained specifically for the mother and her baby. The infant massage will be demonstrated by the researcher on the model, and the mother will be asked to apply it to her baby at the same time.

Group Type: EXPERIMENTAL

Vimala Massage Training for Mothers

Intervention Type: BEHAVIORAL

Mothers will receive Vimala massage training and apply it regularly to their babies at home.

father massage group

Unlike the mother group, in this group, one-to-one training will be given to the fathers of the babies. Each training will be explained specifically for the father and his baby.

Group Type: EXPERIMENTAL

Vimala Massage Training for Fathers

Intervention Type: BEHAVIORAL

Fathers will receive Vimala massage training and apply it regularly to their babies at home.

Control group

In the control group, only one of the parents, mother or father, who fulfills the inclusion criteria will participate.

Group Type: PLACEBO_COMPARATOR

Control Intervention

Intervention Type: OTHER

babies in the control group will not receive any intervention

Interventions

Vimala Massage Training for Fathers

Fathers will receive Vimala massage training and apply it regularly to their babies at home.

Intervention Type: BEHAVIORAL

Control Intervention

babies in the control group will not receive any intervention

Intervention Type: OTHER

Vimala Massage Training for Mothers

Mothers will receive Vimala massage training and apply it regularly to their babies at home.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Infants born at term (38-42 weeks of gestation)
• Aged between 1 and 3 months
• Birth weight between 2500 and 4500 grams
• No health problems other than infantile colic
• Growth and development percentile consistent with current age
• Diagnosed with infantile colic according to Rome IV criteria
• Not yet started any treatment for infantile colic
• No presence of diarrhea or constipation
• Parents with at least primary school education
• Able to speak and write in Turkish
• Provided written and verbal informed consent
• Volunteered to participate in the study

• Infants with acute or chronic medical conditions (e.g., congenital anomalies, metabolic disorders)
• Infants currently receiving any pharmacological or complementary treatment for infantile colic
• Parents with communication difficulties or cognitive impairments that hinder comprehension of study procedures
• Parents who have previously participated in a similar infant massage or infantile colic intervention study
• Parents who are unable or unwilling to complete follow-up assessments or study procedures

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 3 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ataturk University

OTHER

Sponsor Role: collaborator

Kilis 7 Aralik University

OTHER

Sponsor Role: lead

Responsible Party

Elif Simay KOÇ

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Türkan KADİROĞLU, Asst. Prof. Dr.

Role: STUDY_DIRECTOR

Ataturk University

Locations

Atatürk Üniversty

Erzurum, Erzurum, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Central Contacts

Elif Simay KOÇ, Lecturer

Role: CONTACT

kocelifsimay@gmail.com

+90348 814 26 66

Other Identifiers

Ataturk University

Identifier Type: -

Identifier Source: org_study_id